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Luja Set 20081

by Coloplast A/S GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05708932783293 UDI-DIDate2 Sep 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Luja Set
Generic Name
Single-administration urethral catheterization kit, single-use
Model / Ref / Catalog
20081
Primary DI / UDI-DI
05708932783293
510(k) Number
FDA Product Code
FCM, EZD
GMDN Term
Single-administration urethral catheterization kit, single-use
Device Class
Class II
Regulation Number
876.5130
GUDID distribution status
In Commercial Distribution
Size
Catheter Working Length — 13 Inch
Catheter Gauge — 10 French
Catheter Working Length — 33 Centimeter

Related devices

Cleared under the same submission (K250270)

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No